Acute care providers rely on various types of sterilization equipment in conjunction with established procedures to provide contamination-free perioperative care. Further, there are many regulations regarding sterilization and other aseptic practices that acute care providers must comply with. Compliance with these regulations is time-consuming and expensive, but necessary for providing quality health care. In addition, existing sterilization protocols and aseptic requirements are not universally consistent and can vary within each health care facility.
Consequently, there exists in the art different protocols which correspond to a variety of sterilization equipment and methodology regarding the processing of sterile supplies within an acute care facility. The majority of acute care facilities utilize rigid containers wherein surgical instruments and supplies are placed for sterilization, storage and transport. Depending on the processing requirements, acute care facilities must use a variety of container designs and protocols to sterilize instruments and supplies. Examples of such protocols include, but are not limited to: ETO gas, standard steam and flash autoclaving, as well as alternative low temperature methods of sterilization. All of the preceding protocols are well known within the art.
Depending on the method of sterilization, a specific type of sterilant (steam, ETO, Plasma gas, etc.) is introduced under controlled conditions (usually within a chamber) into the sealed container to eliminate microorganisms within, around and on the contents. After sterilization and prior to use, sealed containers serve as a protective repository for storage and transport of the sterilized contents. The majority of conventional sterilization containers are generally rectangular in shape wherein the lid is normally vented with a patterned group of small holes. Occasionally, the bottom of the container will also have vents aligned to mirror the placement of the vents in the lid. Each vent has a filter that allows the entry and exit of the sterilant during the sterilization cycle. After sterilization, the filters provides a protective bacterial barrier which maintains the sterile integrity of the contents during storage and transport.
However, the arrangements of filtered vents known in the art have certain disadvantages. Where vents are present only on the lid, sterilant must enter and exit through the same pathway(s). This can inhibit the introduction, dispersal and exposure of the sterilant throughout the sealed container. The inadequacy of this vent configuration is particularly deficient to meet flash gravity requirements.
Where vents are present on the bottom of the container as well as the lid, the sterilant enters and exits in a column that is created by the direct alignment of the vents in the lid and bottom. This column effect can create "dead spots" within the sealed container whereby the sterilant does not come into sufficient contact to sterilize all of the contents. Most notably, "dead spots" can occur in the corners and along the walls of the container.
Another disadvantage of conventional sterilization containers is fluid retention associated with standard autoclaving, alternative low temperature and especially flash sterilization methods. As the sterilizing media is introduced into the sealed container, condensation forms and collects on the flat (or level) floor of the container. Consequently, instruments located at (or near) the bottom of the container are at risk of corroding due to prolonged contact with the retained condensate.
If the bottom of the container is vented, the barrier properties of filters can be deficient immediately after the door of the sterilizer is opened. This situation is especially a concern when retained moisture is present and the containers are handled or transported while they are still hot. Following the "cool down" period, containers with vented bottoms are also at risk of contamination when retained moisture comes into prolonged contact with the filter elements.
Because of the substantial concern among perioperative professionals over retained moisture, existing containers are seriously limited and inappropriate for the multiple sterilization methods utilized by acute care facilities. The concern regarding retained moisture in sterilization containers is universally applicable to flash sterilization protocols. Since flash sterilization protocols do not have an adequate drying cycle, retained moisture is a normal condition in both frequency (as in always) and magnitude (as in ample) for each and every flash sterilization cycle. This condition is commonly known within the art as "wet packs."